Cleared Traditional

K874482 - REVISED IMMUDIA HEM-SP

K874482 is an FDA 510(k) clearance for REVISED IMMUDIA HEM-SP, manufactured by Schiff & Co.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K874482 · Schiff & Co. · Hematology device
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May 1988
Decision
206d
Days
Class 2
Risk

K874482 is an FDA 510(k) clearance for the REVISED IMMUDIA HEM-SP. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 206 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Schiff & Co. devices

FDA 510(k) Submission Details - K874482

510(k) Number K874482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date May 13, 1988
Days to Decision 206 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 113d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 44
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K874482.
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
IMMUNOCCULT EIA TEST KIT
K871143 · Intl. Immunoassay Laboratories, Inc. · Jul 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986